- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07222839
Impact of Immersive Video Education on Cardiothoracic Surgery Anxiety and Outcomes
March 3, 2026 updated by: Baptist Health South Florida
Exploring the Effect of Visually Immersive Video Education on Cardiothoracic Surgery Patients' Preoperative Anxiety and Postoperative Outcomes
The purpose of this quasi-experimental study is to examine the effect of visually immersive preoperative education on levels of anxiety and patient outcomes in patients undergoing cardiothoracic (open heart) surgery
Study Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Florida
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Miami, Florida, United States, 33143
- South Miami Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Inpatients and outpatients scheduled for elective cardiothoracic (open heart) surgery
Exclusion Criteria:
- Patients undergoing emergent cardiothoracic (open heart) surgery
- Patients with altered mental status
- History of mental health disorders (schizophrenia and bipolar disorder)
- Legally blind/complete blindness and hearing impaired (without hearing aids)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention - Visually Immersive Video Education
Participants receive visually immersive (virtual reality-designed) preoperative video education shown on a tablet that orients patients to the postoperative CVICU environment, equipment, and expected recovery processes.
After viewing the video, the open-heart trained CVICU nurse provides opportunity for discussion, clarification, and questions.
Assignment to this arm occurs during intervention weeks (Weeks 1-2 of each month, per protocol).
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The patients watch a 5-minute visually immersive education video on what to expect postoperatively on arrival to the cardiovascular intensive care unit (CVICU) followed by the opportunity for discussion/explanation and questions.
|
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Active Comparator: Control - Standard Preoperative Education
Participants receive standard preoperative education consisting of a basic verbal explanation of what to expect postoperatively on arrival to the CVICU, followed by opportunity for questions.
Assignment to this arm occurs during control weeks (Weeks 3-4 of each month, per protocol).
|
The patient receives a basic verbal explanation of what to expect postoperatively on arrival to CVICU followed by the opportunity for questions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Anxiety relief (self-report measure 1 - State-Trait Anxiety Inventory)
Time Frame: 30 minutes
|
Patient's anxiety will be measured using the 20-item State-Trait Anxiety Inventory (STAI) (state scale only) (higher scores indicate higher anxiety), taken before and after preoperative education is received.
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30 minutes
|
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Anxiety relief (self-report measure 2 - Visual Analog Scale for Anxiety)
Time Frame: 30 minutes
|
Patient's anxiety will be measured using the Visual Analog Scale for Anxiety (VAS-A), a slider scale of 0 - 100 is used to self-report anxiety (0 = not anxious and 100 = extremely anxious), taken before and after preoperative education is received.
|
30 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Anxiety relief (physiological measure 1 - blood pressure)
Time Frame: 30 minutes
|
Blood pressure is measured before and after receipt of preoperative education.
Increased anxiety may cause elevation of this physiological indicator.
|
30 minutes
|
|
Anxiety relief (physiological measure 2 - heart rate)
Time Frame: 30 minutes
|
Heart rate is measured before and after receipt of preoperative education.
Increased anxiety may cause elevation of this physiological indicator.
|
30 minutes
|
|
Anxiety relief (physiological measure 3 - respiratory rate)
Time Frame: 30 minutes
|
Respiratory rate is measured before and after receipt of preoperative education.
Increased anxiety may cause elevation of this physiological indicator.
|
30 minutes
|
|
Postoperative CVICU Outcome 1 - Length of Stay
Time Frame: Within 30 days after the patient is discharged from CVICU
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Patients' length of stay (# days) in the CVICU.
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Within 30 days after the patient is discharged from CVICU
|
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Postoperative CVICU Outcome 2 - Intubation Time
Time Frame: Within 30 days after the patient is discharged from CVICU
|
Intubation time = Length of time the patient is on mechanical ventilation.
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Within 30 days after the patient is discharged from CVICU
|
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Postoperative CVICU Outcome 3 - Re-intubation
Time Frame: Within 30 days after the patient is discharged from CVICU
|
Re-intubation after initial removal from mechanical ventilation (yes or no).
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Within 30 days after the patient is discharged from CVICU
|
|
Postoperative CVICU Outcome 4 - Blood Sugar Regulation
Time Frame: Within 30 days after the patient is discharged from CVICU
|
Blood sugar regulation = comparison of point-of-care blood sugar levels taken on postoperative day 1 and on the day of discharge from CVICU.
|
Within 30 days after the patient is discharged from CVICU
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Natalie Bermudez, PhD, RN, EBP-C, Baptist Health | Nursing & Health Sciences Research
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 15, 2026
Primary Completion (Estimated)
January 15, 2027
Study Completion (Estimated)
January 15, 2027
Study Registration Dates
First Submitted
September 23, 2025
First Submitted That Met QC Criteria
October 29, 2025
First Posted (Actual)
October 30, 2025
Study Record Updates
Last Update Posted (Actual)
March 4, 2026
Last Update Submitted That Met QC Criteria
March 3, 2026
Last Verified
October 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2359886
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.